A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)

Purpose

The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: - Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; - Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission. No hypothesis testing will be conducted in this study.

Conditions

  • Thrombocythemia, Essential
  • Primary Myelofibrosis
  • Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis
  • Polycythemia Vera

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck & Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready - Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator - ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic remission, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator - Is not currently on a dose hold - Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat

Exclusion Criteria

  • Has received prohibited concomitant medications - Ongoing or planned participation in another investigational study - Has noncompliance in prior bomedemstat study receiving <90% of assigned doses excluding suspensions or holds as assigned by the investigator

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bomedemstat 		Participants will receive oral capsules of bomedemstat once daily for up to 10 years, with the starting dose as the same dose that the participant was on at the time of transition from the feeder study.
  • Drug: Bomedemstat
    10, 15, 20, and 50 mg oral capsules
    Other names:
    • MK-3543
    • IMG-7289

Recruiting Locations

University of Michigan ( Site 6000)
Ann Arbor, Michigan 48109
Contact:
Study Coordinator
734-763-4695

DUHS Duke Blood Cancer Center ( Site 6005)
Durham, North Carolina 27705
Contact:
Study Coordinator
919-668-1608

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)
Columbus, Ohio 43210
Contact:
Study Coordinator
888-577-8839

UPMC Hillman Cancer Center ( Site 6004)
Pittsburgh, Pennsylvania 15232
Contact:
Study Coordinator
412-864-6627

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com